Comparison of the Efficacy of Jilo Animation Approach versus Conventional Tell-Show-Do (TSD) Technique on Cooperation and Anxiety Levels of Children during Dental Practice: A Randomized Controlled Clinical Trials

Statement of the Problem: Modeling is one of the non-pharmacological approaches to manage anxiety behavior and encourage children’s cooperation in dentistry. This method is based on social learning theory in which the children learn the skills of overcoming anxiety and adapting their skills and behaviors during dental treatment. Purpose: The aim of this study was to evaluate the effect of an animated-movie modeling approach, named Jilo, on cooperation and anxiety of children in comparison with the conventional Tell-Show-Do (TSD) method in a dental setting. Materials and Method: In this randomized controlled trial, 50 healthy children (aged 4-6) with no history of dental treatment were recruited and randomly allocated to experimental (n= 24) and control (n= 24) groups. During the first visit, the experimental group watched the Jilo animated movie. After a 30-minute break, they received prophylaxis followed by fluoride therapy. The control group received the conventional TSD technique and then underwent prophylaxis and fluoride therapy. One week later, a dental restoration, which required mandibular nerve block anesthesia, was performed for both groups. The cooperation and anxiety levels of patients were evaluated during two visits using Venham Clinical Cooperation Scale (VCCS) and Venham Clinical Anxiety Scale (VCAS). Results: The mean VCAS in the experimental group was significantly lower compared to the control group during the first and second visits (p= 0.008 and p= 0.044, respectively). The mean VCCS was also significantly lower in the experimental group during the first (p= 0.015) and second visits (p= 0.019) compared to the control group. Conclusion: The application of animated-movie modeling (Jilo) can be recommended as an effective method for preparation of children before the dental treatment session.


Introduction
Behavior management of children is often a major challenge that a dentist has to cope with during a treatment session. Fear and anxiety of children with regard to the prospect of dental treatments are serious problems that families and pediatric dentists need to address [1][2].
Unless it is cured, this problem might persist until adulthood [3]. As far as children are concerned, there is a strong correlation between the anxiety induced by dental treatment and positive prognosis in dentistry; therefore, anxiety management is of paramount importance as a significant factor, which contributes to success in dental treatments [4]. The state of anxiety experienced during a dental treatment is a common condition that, in most cases, seems to originate from childhood. Consequently, a child might refuse to coop-erate and may show disruptive behavior during a treatment session. This could result in multiple complications, including: delayed treatment; occasional failure in conducting the treatment using conventional methods of behavior guidance; refusal to observe dental care; and, eventually, increased prevalence of dental caries [5][6][7].
The first visit to a dentist is very important in terms of shaping the child's behavior, their attitude, and ensuring treatment success. Pediatric dentists often rely on the Tell-Show-Do (TSD) technique to manage a child's anxiety during the examination session prior to the treatment visit. This technique involves explaining the work that is going to be performed on the patient before the actual treatment practice. Next, the child is exposed to a simulation of the work to be done. This technique is based on the premise of acquisition and is conducted by the dentist within the actual treatment environment [8].
Other prevalent behavior management methods include desensitization; visual modeling; play therapy; animated-movie modeling, and pharmacological behavior control [8][9]. According to the modeling technique, which was first introduced by Bandura in 1967, a child is expected to acquire and show a behavior consistent with that of a model they have previously been exposed to in a similar context [10]. A sibling of the patient is employed to educate the child about the expected behavior during the session prior to the treatment visit.
Several studies have focused on the efficacy of animated-movie modeling in reducing the dental treatment anxiety experienced by children. The results indicate that the application of animated-movie modeling can be just as effective as other approaches, such as live modeling techniques and various desensitization methods.
Unlike techniques based on collective learning, the animated-movie modeling approach does not impose spending a great deal of time on the dentist and the caring team [8]. The present study was designed to evaluate the effect of modeling on the behavior of a sample population of Iranian children using an animated-movie, which simulated an actual dental-office environment with animated characters. Furthermore, the study aimed to compare the efficacy of this method versus the conventional TSD technique.

Materials and Method
This randomized controlled single blinded parallel-gro-  to verify their eligibility to enter the study, a pediatric dentist conducted an interview was with the children's parents or their primary caregivers to obtain medical and dental history. Then the purpose and method of the study were described for the parents. The informed consent form and the personal information section of the patient's file were signed and filled by parents.
The sample size in this study was considered 25 in each group regarding Kebriaee et al. study [11] with the type 1 error level of 5%, type 2 error level of 20%, and dropout rate of 10%. Eventually, 50 patients were entered into the study and randomly assigned to two equal groups of control (n=25) and experimental (n= 25). Two appointments were scheduled for each patient with oneweek interval between. One patient from each group was excluded from the study after they refused to show up for the second treatment session.

First appointment
Adopting a balanced randomized block design and using the randomizer.com website, each patient was allocated to either of the following groups by the second author.

The control group: Tell-Show-Do group (TSD)
In this group, the patient learned about the dental procedures and instruments using Tell-Show-Do technique during the first visit. Then patients received prophylaxis with rubber cup and low speed handpiece followed by fluoride therapy with %1.1 sodium fluoride gel as a preparation stage to familiarize these patients with the environment of a dental office. At the end of the session, a reward gift was given to the patient to serve as an encouraging positive reinforcement.

The experimental group: Modeling using an animated movie (Jilo)
During the first visit, the patient and the accompanying parent were led to sit in a quiet room and watch an animated movie entitled "Jilo goes to a dentist" (https:// www.aparat.com/v/g7wFt).The storyline of this animation is set in the animal world; one day, a young bear called Jilo goes to a dentist with his mother. Dental instruments and procedures are designed in the form of objects and concepts that a child can understand, and that involve their imagination. For example, the suction procedure has been modeled using an elephant's trunk and its power to suck in water. After watching the animated movie, the patients were let to rest for 30 minutes, which was followed by prophylaxis and fluoride therapy in the same manner as the control group.
One week later, during the second visit, the patients were reminded of the atmosphere of the animated movie and its characters before undergoing a restoration that required mandibular nerve block injection.

Second appointment
A week after the first appointment, the patient returned to the clinic. The patient was asked to take a seat on a dental unit without the presence of their parent. Mandibular nerve block injection was performed in conjunction with topical anesthesia. Once local anesthesia was ensured, an access cavity was prepared to remove the caries and restore the tooth. It was made sure that all  Venham Clinical Anxiety Scale (VCAS), which are among the most frequent behavior scoring models [12][13]. These scales contain six defined behavioral levels that range from 0 to 5. The highest score defines the highest anxiety level, or the least cooperation (Table 1 and 2).
If there were any differences in the scores of the reviewers, the film was reviewed and both reviewers achieved an agreement on a score.
Thus for each patient, two scores on the levels of anxiety and cooperation for the first visit (prophylaxis and fluoride therapy) and two scores for the second visit (restoration), were obtained. In order to confirm the intra-examiner reliability, 5 patients from each group were randomly selected and their films were reevaluated and scored, and correlation coefficient was obtained. No changes were made to the design and outcomes of the study after trial commenced.   Table 3 shows demographical information of participants in each group. There was no significant difference in gender distribution (p= 0.113) and mean age between the two groups (p= 0.503). The correlation between the two evaluators showed that there was a high  Figure 2). Considering the effect of gender on the level of anxiety and cooperation, there were no statistically significant differences between two genders in both groups (Figure 3 and 4). Moreover, in assessing the  Table 4).
The comparison of the mean changes in anxiety and cooperation in two visits between the two groups showed that in both groups, the level of anxiety and cooperation in the second visit were lower than the first visit and in the Jilo group, this decrease was more pronounced. However, there was no significant difference in the reduction of anxiety and cooperation in the second visit between the two groups ( Table 5).

Discussion
The modeling technique is based on a psychological theory according to which people learned how to behave in a particular situation through observing others' behavior therein. This technique involves employing a model, which sets an appropriate example of behavior.
The child is then expected to show the required correct behavior, which is rewarded by an encouraging response and reinforced through a positive result.
The desirable outcome will be reduced anxiety of the child [15]. The Tell-Show-Do (TSD) technique is commonly used to acquaint the patient with the unfamiliar environment of a dental office as well as the treatment procedures, particularly at onset. In 1959, Addlestone introduced this technique, which rests on a number of tenets from the acquisition/learning theory,  Comparison between the two groups was done using Mann-Whitney U test and ever since, it has served as the foundation for child behavior control [8]. This technique can be applied as a standardized approach. Most often, pediatric dentists utilize imaginary expressions and substitute vocabulary in order to enhance the clarity of messages they need to get across as well as to improve the conceptualization of the child. This substitute language resembles a second language whereby the pediatric dentist and the child communicate [10].
The present study was designed to evaluate the efficacy of watching an animated movie, which educates the child about the entire dental-office environment and the treatment procedures by involving the child's imagination. The produced animation simulates dental instruments and procedures using objects and animated animals that a child can readily conceptualize.
The findings of this study suggest that, when the child comes to a dental treatment office, watching an animation with animated characters, which engages the child's imagination, can be more effective in reducing the child's anxiety and improving their cooperation than the TSD technique alone.
The target group of this study was defined as 4-6- year-old children, similar to another study by Paryab et al. [16] and many others [16][17]19]. The study population was selected from children at preschool stage to eliminate the confounding influence of school on the behavior of the child as well as their cognitive level [20], and to remove other age-related confounding factors. As a constant finding, in most studies, behavioral management problems are more common in early childhood, especially in preschool children [9,21].
In this study, the two groups did not have a significant difference in age and sex, and therefore there was no confounding factor in this view.  [18,24].
In the Jilo group, the level of anxiety slightly increased and the level of cooperation showed a slight decrease during the second visit, but these changes were not statistically significant with the changes in the control group. Therefore, it is fair to claim that exposure to the animated movie used in this study played an effective role in reducing anxiety and improving cooperation of the patients. In addition, the one-week interval between the first visit, when the animation was watched, and the second visit indicated the long-term effect of the experimental technique at least for one week.
To date, various tools have been introduced for the purpose of evaluating and scoring the cooperation and anxiety levels in children with regard to dental visits [25]. Similar to the method used by Paryab et al. [16], this experiment utilized Venham index for scoring the patients' behavior. Accordingly, the cooperation and anxiety levels of the children, observed in the recorded films, were measured using VCCS and VCAS, which are regarded as common behavior scoring models. These models (Venham index) have been generally confirmed in terms of reliability and validity, and have been widely used in dental research to assess children's anxiety and negative responses [13].
It is worth mentioning that the application of Behavior index alone may not be sufficient when it comes to evaluation of the anxiety level. Thus, it is recommended to utilize a combination of behavior index and physiological index in future studies.

Conclusion
The findings of the current study reveal that the animated-movie modeling technique can be used to produce a desirable effective influence during the preparation prior to visit as well as the dental treatment sessions involving children aged 4-6. This technique can be used in conjunction with the conventional Tell-Show-Do technique to generate a positive synergic effect.

Acknowledgments
This study was based on a thesis (No=940530) written by Reihaneh Rafie Nezhad submitted to the dental school in partial fulfillment of the requirements for the DDS degree. The authors would like to extend their appreciation to the vice chancellor for research, of the Mashhad University of Medical Sciences (MUMS) for the financial support of this work. In addition, we extend our appreciation to Dr. Behzad Latifian, Mashhad, Iran, for designing the animated movie: "Jilo goes to a dentist".

Conflicts of Interest
Dr. Sahebalam is one of the producers of "Jilo goes to a dentist".